DePuy Spine Recalls Pipeline LS Dilators for Uncleared Neuromonitoring Use
DePuy Spine is recalling 105 Pipeline LS Access System dilators and holding clips because they were used for neuromonitoring, a function for which the devices are not cleared.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations or injuries. The hazard is the use of a device for an uncleared function, which fits the criteria for a moderate severity recall involving regulatory non-compliance without reported harm.
Plain-English summary
DePuy Spine, Inc. is recalling 105 units of the PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated, and associated Holding Clips. The recall is due to the devices being used for a secondary function of neuromonitoring, for which they are not 510(k) cleared by the FDA.
The affected products are intended for the sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. The recall covers units distributed nationwide, including specific states such as AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.
Healthcare providers and facilities should stop using the affected devices for neuromonitoring and contact DePuy Spine for instructions on return or replacement. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
- Manufacturer
- DePuy Spine, Inc.
- Hazard
- Affected units
- 105
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 287105010
Distribution
Part of a larger recall action
This product is one of 5 recalled by DePuy Spine, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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